Non-Invasive Testing for Liver Disease Treatment Builds Hope
One of the difficult things about liver disease is the monitoring and testing required to see what’s really going on with the liver. Up until recently, this testing has been fairly invasive, mainly in the form of biopsies.
At the European Association for the Study of the Liver Congress 2025 in Amsterdam, significant progress was showcased in the development of non-invasive tests (NITs) for diagnosing and treating metabolic dysfunction-associated steatohepatitis (MASH), potentially transforming the field away from traditional invasive liver biopsies. Liver biopsies, while historically the gold standard for diagnosing liver fibrosis, are invasive, costly, and variable in accuracy depending on specimen size and pathologist interpretation.
Research presented at EASL demonstrated that NITs, particularly Agile 3+ and Agile 4 scores derived from vibration-controlled transient elastography, offer excellent diagnostic accuracy for advanced fibrosis and cirrhosis in high-risk patients with Type 2 diabetes. Companies like 89bio are already implementing various NITs including FAST, AGILE3+, VCTE, FIB-4, and Pro-C3 in their clinical programs, with their Phase 2b ENLIVEN study showing these tests effectively identified advanced MASH patients and correlated with histological improvements.
Liver Disease Treatment Improvements
The shift toward NITs promises multiple benefits: accelerated drug development timelines, improved patient experience through more convenient trial participation, reduced variability in outcomes, and improved reliability for regulatory approvals. This transition represents not merely a methodological change but a fundamental transformation in hepatology that could significantly improve patient outcomes and therapeutic advancement.
You can read more of this timely article here by Teresa Perney of 89bio: “89bio is Looking to the Future: The Excitement is Building Around the Promise of Non-Invasive Tests.”
“Researchers at EASL shared findings that suggest NITs offer a more accurate assessment compared to liver biopsies. The discussion surrounding the effectiveness Agile 3+ and Agile 4 scores derived from vibration-controlled transient elastography (VCTE) was particularly interesting, with one study evaluating its diagnostic performance in patients with biopsy-proven MASLD with Type 2 diabetes mellitus (T2DM). Notably, the Agile scores demonstrated excellent diagnostic accuracy for advanced fibrosis and cirrhosis in these high-risk patients; therefore, offering a reliable and non-invasive option for fibrosis assessment. Another study analyzed NIT-based pre-screening strategies and reported potential enhancements in recruiting trials for at-risk MASH patients. These strategies could streamline clinical trial recruitment by reducing the number of invasive biopsies needed to identify eligible patients.”
